Randomized Open Investigation Determining Steroid Dose

Covid19 Clinical Trial

— ROIDS-Dose  

Official title:

Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834375
• Other study ID #: 21-0171
• Status: Completed
• Phase: Phase 3
• Start date: March 19, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: July 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.

Description:

Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 29, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults greater or equal than 18 years old

• COVID-19 infection confirmed by positive PCR test

• Hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen

Exclusion Criteria:

• Corticosteroid use for > 48h within the past 15 days prior to enrollment

• Use of steroids with doses higher than the equivalent to dexamethasone 6 mg

• Use of immunosuppressive drugs

• Pregnant women

• Chronic oxygen use

• Known history of dexamethasone allergy

• DNR / DNI

• Patient or proxy cannot consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Weight-based dexamethasone dose
Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure

Locations

Country	Name	City	State
United States	Northwell Health	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Edalatifard M, Akhtari M, Salehi M, Naderi Z, Jamshidi A, Mostafaei S, Najafizadeh SR, Farhadi E, Jalili N, Esfahani M, Rahimi B, Kazemzadeh H, Mahmoodi Aliabadi M, Ghazanfari T, Sattarian M, Ebrahimi Louyeh H, Raeeskarami SR, Jamalimoghadamsiahkali S, Khajavirad N, Mahmoudi M, Rostamian A. Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial. Eur Respir J. 2020 Dec 24;56(6):2002808. doi: 10.1183/13993003.02808-2020. Print 2020 Dec. — View Citation

RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17. — View Citation

Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MVAO, Baldassare FP, Costa ELV, Moura RAB, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, Azevedo LCP; COALITION COVID-19 Brazil III Investigators. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1307-1316. doi: 10.1001/jama.2020.17021. — View Citation

Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7. — View Citation

WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Sterne JAC, Murthy S, Diaz JV, Slutsky AS, Villar J, Angus DC, Annane D, Azevedo LCP, Berwanger O, Cavalcanti AB, Dequin PF, Du B, Emberson J, Fisher D, Giraudeau B, Gordon AC, Granholm A, Green C, Haynes R, Heming N, Higgins JPT, Horby P, Juni P, Landray MJ, Le Gouge A, Leclerc M, Lim WS, Machado FR, McArthur C, Meziani F, Moller MH, Perner A, Petersen MW, Savovic J, Tomazini B, Veiga VC, Webb S, Marshall JC. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA. 2020 Oct 6;324(13):1330-1341. doi: 10.1001/jama.2020.17023. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality at 28 Days	All cause mortality at 28 days.; Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge	28 days
Secondary	Number of Participants Admitted to the ICU	Number of participants that required admission to the ICU	28 days
Secondary	Days of Stay in the Intensive Care Unit	ICU length of stay	28 days
Secondary	Days of Hospitalization	Duration of hospitalization	28 days
Secondary	Number of Participants That Required Higher Levels of Oxygen Supplementation	Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation	28 days
Secondary	Number of Participants That Required Invasive Mechanical Ventilation	Escalation to invasive mechanical ventilation	28 days
Secondary	Duration of Invasive Mechanical Ventilation	Total days requiring invasive mechanical ventilation	28 days
Secondary	Number of Participants That Required ECMO	Refractory hypoxemia requiring ECMO	28 days
Secondary	Number of Participants That Required Tracheostomy	Need for tracheostomy	28 days
Secondary	Number of Participants That Developed Secondary Bacterial or Fungal Infections	Culture positive evidence of secondary bacterial or fungal infections	28 days
Secondary	Number of Participants That Developed Clinically Significant Hyperglycemia	Defined as need for insulin drip or ICU admission to control hyperglycemia	28 days
Secondary	Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital	Need for oxygen supplementation at hospital discharge; Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.	Until hospital discharge
Secondary	Subjective Symptoms at 28 Days	Subjective symptoms questionnaire at 28 days	28 days
Secondary	Disposition Upon Discharge	Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired	At hospital discharge